Diabetic foot syndrome Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
Conditions
Interventions
All enrolled patients will receive 62.5 mg bosentan (Tracleer®) twice a day (BID) for 4 weeks followed by 125 mg bosentan BID for 3 months. Total duration of treatment and follow up is 4 months.
Sponsors
University Hospital Zürich (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provided written informed consent 2. Male and female patients aged > 18 years 3. With diabetic foot syndrome (irrespective of catheter technical or surgical revascularisation plans and irrespective of the presence of any infection)
Exclusion criteria
Exclusion criteria: 1. Trophic skin lesions due to other diseases than diabetes 2. Planned amputation within the following 4 months 3. Revascularisation within 4 weeks prior to inclusion 4. Systolic BP < 85 mm Hg 5. Hb <75% of the lower limit of normal 6. Severe malabsorption or any severe organ failure or any life-threatening state 7. Contraindications to the use of bosentan 8. Previous treatment with bosentan 9. Treatment with botulinus toxin, prostanoids, sildenafil or any other experimental treatment 10. Body weight< 40 kg 11. Patients unable to provide informed consent and comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Transcutaneous oxygen tension 2. Reactive hyperemia Measured at 2 weeks, 1 month and 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Size and number of the ischemic skin lesions 2. Toe blood pressure 3. Local pain Measured at 2 weeks, 1 month and 4 months | — |
Countries
Switzerland
Outcome results
None listed